Steel Spore Disc Biological Indicators
An inoculated carrier, 6 mm steel disc, of Bacillus atrophaeus (Cell Line 9372) with a population level of 103,104, 105 or 106 or Geobacillus stearothermophilus (Cell Line 7953) with a population level of 103, 104, 105 or 106.
These Biological Indicators (BIs) for use in monitoring Vaporized Hydrogen Peroxide (VH2O2) sterilization processes. The BIs are designed for monitoring processes whether placed directly into the chamber, positioned in areas of a device which are the most difficult to sterilize or distributed
- Convenient shelf packages of 100 units per box
- Products are accompanied by a Certificate of Analysis and are certified with population, purity, and resistance characteristics (D value, survival and kill where applicable)
- ISO 11138-1 Compliant
The Spore Discs are utilized to monitor VH2 O2 sterilization process efficacy. The Spore Discs are labeled For Industrial Use Only.
Place Spore Discs (a minimum of 10 per exposure is recommended) inside representative materials to be sterilized. Package or wrap product as usual, if applicable. Locate the test packages or Spore Discs in areas most difficult to sterilize, as outlined in your specific sterilization validation protocol (usually four corners front, four corners rear, center-center and center-top) or according to standard operating procedure. Run the cycle.
- After sterilization or exposure, remove Spore Discs or product from sterilizer.
- Aseptically transfer the Spore Discs to Soybean Casein Digest Broth (SCDB).
- Transfer one Spore Disc which has not been exposed in a sterilization process as a Positive Control.
Incubation: At least one unused tube of culture medium from the same lot should be incubated with the test series as a Negative Control. Place the cultured Spore Discs, the Positive Control and the Negative Control in an incubator set at 55°C to 65°C. Incubate for a minimum of seven days or per a validated reduced incubation period.
Monitoring: Examine the Spore Discs daily during incubation. Record observations.
|Disc Diameter||6 mm|
|Pouch Dimensions||29 mm x 75 mm|
|Population||1.0 to 5.0 x 10x per disc, where x = the population level of the Spore Disc|
|Purity||No evidence of contamination present in sufficient numbers to adversely affect the finished product.|
Resistance||D value at 55°C ± 5°C, 2.3 mg/L
1.0 to 3.0 minutes|
|Post-Market Criteria||Population: 50% to 300% of certified population
D value: ± 20% of the certified D value|
|Storage and Shelf Life|
|15°C to 30°C||Sunlight||Keep away from sunlight|
|Relative Humidity||20% to 70%||Moisture||Keep dry|
|Shelf Life||19 Months from the date of manufacture||Radioactivity||Protect from heat and radioactive sources|
|Short excursions outside the range of temperature and relative humidity recommended will not impact the performance of the Spore Discs. Do not use damaged Spore Discs. Do not use after the expiration date. The Spore Discs contain live cultures and should be handled.|
At Liquidyne, we prioritize our commitment to quality and consistency. In 2017 we achieved ISO 9001:2015 Quality Management System certification to ensure we can repeatedly deliver consistently high-quality products and solutions. Being an ISO 9001 facility, together with our USP Class VI Testing, ASME Bioprocessing Equipment (BPE), and EHEDG certification guarantee, we have the methodologies to assure quality. We will quickly and accurately rectify any issues if any of our products are ever in non-conformance.
"Thanks so much! What a quick turn around. It is a pleasure working with Liquidyne."
Process Development Manager
"I received the cart yesterday, thanks for the fast delivery! It feels sturdy. I sat on it. It does not bounce. It is also easy to clean and wipe or wash down."
Vice President, Analytical Development and Manufacturing
"Thanks again for reacting so quickly and meeting me halfway with the element. We will be able to get installed and have things keep moving overnight with the night crew. The little things like this are always greatly appreciated when working with Liquidyne."
“This pump cut our processing time from 3 days to 1 shift. I’m not giving this pump back. You will have to come and get it if you want it... and that won’t likely happen.”
VP Antibody Manufacturing